BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3212336 · Received July 9, 2013

    Report

    Report Number
    3003742446-2013-00085
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, BENICAR, BIVALIRUDIN, PLAVIX, AND IMDUR. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT UNDERWENT REVASCULARIZATION APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, ANGINA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, ASTHMA, HYSTERECTOMY AND GASTROESOPHAGEAL DISEASE. AT THE TIME OF INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH STABLE ANGINA AND +VE FUNCTIONAL TEST FOR ISCHEMIA. THE 1ST LESION WAS IN THE DISTAL RCA DESCRIBED AS 14MM IN LENGTH, CLASS B1 AND DE NOVO WITH 99% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. AS PLANNED, THE LESION WAS PREDILATED WITH A 2X15MM BALLOON AT 12ATMS. A 2.25X18MM CYPHER RX WAS IMPLANTED AT 14ATMS. THE 2ND LESION WAS IN THE MID RCA THAT WAS DESCRIBED AS 8MM IN LENGTH, CLASS B1 AND DE NOVO WITH 66% STENOSIS. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER. A 2.75X13MM CYPHER RX WAS IMPLANTED AT 16ATMS. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. APPROXIMATELY 29 MONTHS LATER, THE PATIENT UNDERWENT REVASCULARIZATION OF THE MID AND PROXIMAL RCA. THE INDICATION FOR THE REPEAT REVASCULARIZATION WAS ANGINA. AS PER SITE, THE STUDY STENTS WERE NOT RESTENOSED AND NEW LESIONS WERE NOT WITHIN 5MM OF STUDY STENTS AS STUDY STENTS WERE INITIALLY IMPLANTED IN THE PDA; HOWEVER, AS PER CRF THEY WERE IMPLANTED IN THE MID AND DISTAL RCA. ALSO THE SITE INDICATED THAT THE STUDY STENTS NOTED TO BE PATENT. THE DISTANCE BETWEEN NEW LESIONS AND OLD STUDY STENTS WAS AROUND 10 MM. THE EVENT RESOLVED WITHOUT SEQUELAE. ADDITIONAL CLARIFICATION REGARDING LOCATION OF STUDY STENTS AND NEW LESIONS HAS NOT BEEN PROVIDED DESPITE MULTIPLE REQUESTS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND HYPERLIPIDEMIA. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00084 AND 3003742446-2013-00085.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT UNDERWENT REVASCULARIZATION APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE. AT THE TIME OF INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH STABLE ANGINA AND +VE FUNCTIONAL TEST FOR ISCHEMIA. THE 1ST LESION WAS IN THE DISTAL RCA DESCRIBED AS 14MM IN LENGTH, CLASS B1 AND DE NOVO WITH 99% STENOSIS. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. AS PLANNED, THE LESION WAS PREDILATED WITH A 2X15MM BALLOON AT 12ATMS. A 2.25X18MM CYPHER RX WAS IMPLANTED AT 14ATMS. THE 2ND LESION WAS IN THE MID RCA THAT WAS DESCRIBED AS 8MM IN LENGTH, CLASS B1 AND DE NOVO WITH 66% STENOSIS. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER. A 2.75X13MM CYPHER RX WAS IMPLANTED AT 16ATMS. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. APPROXIMATELY 29 MONTHS LATER, THE PATIENT UNDERWENT REVASCULARIZATION OF THE MID AND PROXIMAL RCA. THE INDICATION FOR THE REPEAT REVASCULARIZATION WAS ANGINA. AS PER SITE, THE STUDY STENTS WERE NOT RESTENOSED AND NEW LESIONS WERE NOT WITHIN 5MM OF STUDY STENTS AS STUDY STENTS WERE INITIALLY IMPLANTED IN THE PDA; HOWEVER, AS PER CRF THEY WERE IMPLANTED IN THE MID AND DISTAL RCA. ALSO THE SITE INDICATED THAT THE STUDY STENTS NOTED TO BE PATENT. THE DISTANCE BETWEEN NEW LESIONS AND OLD STUDY STENTS WAS AROUND 10 MM. THE EVENT RESOLVED WITHOUT SEQUELAE. ADDITIONAL CLARIFICATION REGARDING LOCATION OF STUDY STENTS AND NEW LESIONS HAS NOT BEEN PROVIDED DESPITE MULTIPLE REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313056 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15227517

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention